BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BeneVision N19 Patient Monitor

    Reg #: 2221819 · FEI: 2221819 · Expires 2025
    View on FDA
    Products
    31
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    31

    Registration Details

    Registration Name
    MINDRAY DS USA, Inc.
    Registration Number
    2221819
    FEI Number
    2221819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    800 MACARTHUR BLVD.
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213799

    Owner / Operator

    Firm Name
    Mindray DS USA, Inc.
    Operator Number
    10025908
    Address
    800 MacArthur Blvd
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    James Clifford

    Products

    Device Name Product Code
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Oximeter DQA
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Alarm, Blood-Pressure DSJ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Transducer, Blood-Pressure, Extravascular DRS
    Electrode, Cutaneous GXY
    Index-Generating Electroencephalograph Software OLW
    Computer, Blood-Pressure DSK
    Detector And Alarm, Arrhythmia DSI
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Stimulator, Nerve, Peripheral, Electric KOI
    Tester, Electrode, Surface, Electrocardiographic KRC
    Monitor, St Segment With Alarm MLD
    Oximeter, Tissue Saturation MUD
    Reduced- Montage Standard Electroencephalograph OMC
    Plethysmograph, Impedance DSB
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Monitor, St Segment MLC
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    BeneVision N19 Patient Monitor BeneVision N12 Patient Monitor BeneVision N22 Patient Monitor BeneVision N17 Patient Monitor BeneVision N15 Patient Monitor BeneVision N1 Patient Monitor BeneVision N Series Patient Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198